The Institute for Clinical and Economic Review (ICER) systematically reviewed and synthesized existing evidence from clinical studies to assess the comparative clinical effectiveness for targeted immune modulators (TIMs) for moderate-to-severe ulcerative colitis (UC).
ICER’s draft scoping document was developed with input from diverse stakeholders, including patients, organizations, clinicians, and manufacturers of the agents of focus in this review. ICER looks forward to continued engagement with stakeholders throughout its review and encourages comments to refine their understanding of the clinical effectiveness and value of TIMs for UC.
Ulcerative colitis causes long-lasting inflammation and ulcers (sores) in the digestive tract and is typically marked by periods of remission and recurrence of symptoms.
Ulcerative colitis management has the goal of inducing a clinical response to treatment or effect a complete remission of the symptoms during a short-term “induction” phase of treatment, and maintain response or remission via long-term “maintenance” therapy.
ICER’s Conclusion From Report
In the recent Draft Evidence Report conducted by ICER, ICER’s conclusion stated that all TIMs are not cost-effective. ICER’s model does not reflect current clinical practice and does not account for the value of these important therapies beyond limited clinical outcomes, including value to society and improving patients’ quality of life.
iDose by Baysient is revolutionizing the way inflammatory-disease patients are treated, improving the effectiveness of Infliximab, and ensuring patients do not develop drug-resistant antibodies too soon into treatment. By providing individualized dosing regimens, iDose reduces the chance of drug failure, helping patients reach and maintain remission while lowering overall healthcare costs.
Therapeutic drug monitoring (TDM) is the clinical practice of measuring specific drugs at designated intervals to maintain a constant concentration in a patient’s bloodstream, thereby optimizing individual dosage regimens. TDM is used mainly for monitoring drugs with narrow therapeutic ranges, drugs with marked pharmacokinetic variability, medications for which target concentrations are difficult to achieve.
Baysient is thankful for the opportunity to provide comments on the Draft Evidence Report conducted by ICER. Read our comments here.
We recommend that the Final Evidence Report identify trending changes to the standard of care that have the potential to alter the analytical conclusions of the report. These trends include the impact of:
- Increasing the application of therapeutic drug monitoring (TDM) combined with clinical decision support (CDS) as the standard of care.
- Filling “knowledge gaps” (i.e. the relationship between administered dose and trough concentration) in current clinical practice guidelines.
- Providing sufficient evidence to recommend the route use of TDM with TNF-alpha inhibitors.
- Applying better-clinical-outcome-at-lower-cost alternative payment models to individualized infliximab therapy incorporating TDM combined with CDS.
- Changing the U.S. infliximab label making it consistent with monographs that include the use of TDM with infliximab.
- Providing health care providers with scientifically appropriate and statistically sound dosing information derived from the laboratory assays provided by infliximab manufacturers or other licensed laboratories.
Data supporting these trends are included in the results of clinical validation studies that are currently moving through the process of publication. The studies of interest are:
- Titrate (Induction for Acute Ulcerative Colitis), NCT03937609
- Precision Dosing of Infliximab Versus Conventional Dosing of Infliximab (PRECISION), NCT02453776
- Precision IFX: Using a Dashboard to Individualize Infliximab Dosage, NCT02624037
- Optimization of infliximab therapy in inflammatory bowel disease using a dashboard approach – an Indian experience
- Compassionate Use in Acute Severe IBD; Medical University of Vienna, Austria
The study results indicate that in clinical practice, the combination of TDM and CDS can alter the status of less expensive infliximab to “biobetter,” relative to more expensive alternatives. Over the next 24 months, additional scrutiny of the clinical data may verify factors to be added to the ICER models used to evaluate the effectiveness and value of targeted immune modulators.
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